FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE
Report
- Report Number
- 1037905-2021-00210
- Event Type
- Malfunction
- Date Received
- May 20, 2021
- Date of Event
- April 21, 2021
- Report Date
- July 2, 2021
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- KNS
- UDI-DI
- 10827002347110
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
CONTINUED: SECTION E. INITIAL REPORTER; OCCUPATION: AREA REPRESENTATIVE CONTINUED: SECTION G. PMA/510(K) #: K172288. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. A PICTURE WAS ALSO PROVIDED AND REVIEWED. IT SHOWS THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAS DISCONNECTED FROM THE CATHETER. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. OUR PHOTO AND LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAS DISCONNECTED FROM THE CATHETER. THE CUTTING WIRE IS INTACT AND REMAINS SECURELY ATTACHED TO THE SPHINCTEROTOME AT THE PROXIMAL END. HOWEVER, DUE TO THE CATHETER AND SECURING COMPONENT DISCONNECTION, THE DISTAL END OF THE CUTTING WIRE IS NO LONGER CONNECTED TO THE SPHINCTEROTOME CATHETER AT THE DISTAL END. THE SECURING COMPONENT HAS A LONGER SECTION MEASURING 3.0 MM AND A SHORTER SECTION MEASURING 2.0 MM, THEREFORE NO PART OF THE DEVICE IS MISSING. LIQUID WAS ALSO OBSERVED WITHIN THE CATHETER. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER CAN OCCUR IF THE TIP OF THE SPHINCTEROTOME IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER: "DO NOT OVER FLEX OR BOW TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE CUTTING WIRE TO BREAK." OTHER FACTORS THAT CAN CONTRIBUTE TO SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER: "UPON REMOVING DEVICE FROM PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME. CAREFULLY REMOVE PRECURVED STYLET FROM CANNULATING TIP." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
INITIAL REPORTER; OCCUPATION: AREA REPRESENTATIVE. PMA/510(K) #: K172288. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURE PROVIDED IN RESPONSE TO THIS REPORT, BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE PICTURE PROVIDED WE CANNOT COMPLETE A FULL EVALUATION. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. OUR EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE PHOTO OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAS DISCONNECTED FROM THE CATHETER ON THE REPORTED DEVICE. THE CUTTING WIRE IS INTACT AND REMAINS SECURELY ATTACHED TO THE SPHINCTEROTOME AT THE PROXIMAL END. HOWEVER, DUE TO THE CATHETER AND SECURING COMPONENT DISCONNECTION, THE DISTAL END OF THE CUTTING WIRE IS NO LONGER CONNECTED TO THE SPHINCTEROTOME CATHETER AT THE DISTAL END. THE SECURING COMPONENT APPEARS TO HAVE A LONGER SECTION MEASURING 3.0 MM AND A SHORTER SECTION MEASURING 2.0 MM. THEREFORE NO PART OF THE DEVICE APPEARS TO BE MISSING. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: THE PHOTO PROVIDED BY THE USER SHOW THE CUTTING WIRE SECURING COMPONENT (ANCHOR) SEPARATED FROM THE CATHETER. WE COULD NOT CONDUCT A COMPLETE INVESTIGATION HOWEVER BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER CAN OCCUR IF THE TIP OF THE SPHINCTEROTOME IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER: "DO NOT OVER FLEX OR BOW TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE CUTTING WIRE TO BREAK." OTHER FACTORS THAT CAN CONTRIBUTE TO SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER: "UPON REMOVING DEVICE FROM PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME. CAREFULLY REMOVE PRECURVED STYLET FROM CANNULATING TIP." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE PHYSICIAN TRIED TO PERFORM A SECOND CUTTING PROCEDURE AND WHEN THE SPHINCTEROTOME WAS TWISTED THE TIP OF THE WIRE [CUTTING WIRE SECURING COMPONENT] GOT [CAME] OUT OF SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756192 | FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE | KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | COOK ENDOSCOPY | G34711 | W4366830 | 10827002347110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | PENTAX VIDEO DUODENOSCOPE, ED34-I10T. |